"Home-Use" Ultrasound Device for Remote Follicle Monitoring Enters NMPA Priority Review Channel

  • 【Abstract】: (Product Innovation) A Hangzhou-based medtech unicorn has announced that its portable, smartphone-connected ultrasound probe designed for patient self-monitoring has entered the NMPA Priority Review channel. The device uses AI guidance to help patients capture follicle images at home, which are then reviewed remotely by clinicians.

  • Business Insight: This technology solves the biggest pain point of IVF: frequent hospital visits. By enabling "Remote Monitoring," clinics can expand their catchment area significantly, serving patients in lower-tier cities without requiring them to stay in hotels near the center for weeks. This effectively creates a "Hub-and-Spoke" model without physical infrastructure.

  • 【Keywords】: #RemoteMonitoring #HomeUltrasound #DigitalHealth

  • 【Source】: NMPA CDE Center / 36Kr (Feb 14, 2026)

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